The present invention relates generally to the treatment of bleeding sites within the digestive tract, and more particularly to esophago-gastric and gastroduodenal balloon tamponade devices, and methods for their placement and maintenance in position. This invention also relates to methods for delivering therapeutic substances using these devices.
It is often necessary to medically treat bleeding sites within the esophagus. One method which has been used to treat such bleeding sites is to exert pressure on them using a balloon tamponade device. Such a device has included a balloon mounted over a tube which can be advanced down the esophagus. Then, the balloon is inflated and used to provide pressure to the site. Serious complications can occur when a device is incorrectly placed and inflated, sometimes producing esophageal rupture. More commonly, the devices are inappropriately placed and are thus ineffective to properly treat the bleeding sites. It is therefore desirable to have a device which can be used in connection with an endoscope so that the placement procedure can immediately follow diagnostic endoscopy and be directly monitored. Additional complications can arise because tamponade devices of the prior art block the esophagus so that normal feeding and swallowing by the patient is impossible and gastric lavage is difficult. This may be especially true where, as in the prior art known to applicant, the tube over which the balloon is mounted extends completely up and out of the patient's esophagus when the device is in place. This arrangement leaves no convenient passage through the mouth to the stomach.
Among the prior art devices, U.S. Pat. No. 4,464,175 to Altman et al. discloses a balloon-tube assembly comprising a multipurpose tamponade and thrombosclerotherapy tube. The tube has an open proximal end and windows spaced approximately 1.5 centimeters from a closed distal end. A modified metal cap diaphragm fits into the tubes open proximal end, and a latex balloon mounted over the tube is connected to a manometer by means of a polyvinyl catheter. The Altman et al. patent describes that the device therein permits effective gastric lavage at the same time that controlled esophageal tamponade is taking place. The device of Altman et al., however, is generally bulky and thus may be more difficult to place and as well uncomfortable to the patient. Additionally, a device such as that disclosed in Altman prevents normal feeding and swallowing functions because of its closed distal end and because its proximal end extends up the esophagus and out of the patient's mouth. As noted, this arrangement provides no convenient passage through which materials may pass to the stomach. Moreover, as disclosed, the Altman device is intended for brief use during gastric lavage and endoscopic sclerotherapy with accompanying tamponade. The Altman device is positioned through the mouth, has no method for prolonged maintenance of its esophageal position, and is intended to be withdrawn immediately after sclerotherapy.
U.S. Pat. No. 4,752,286 to Okada discloses a small diameter (O.D. approx. 2.7 to 4.0 mm) double lumen balloon tube which may be directed through the esophagus prior to the treatment of a varix therein. According to the Okada patent, the varix is thereafter punctured and the balloon tube is partially withdrawn to position the balloon adjacent the punctured varix. Then, an inflation lumen is used to inflate the balloon to provide pressure to check the bleeding. Okada discloses that the other lumen of the device therein may be equipped with suction holes on either side of the varix-compressing balloon. As described in Okada, suction holes proximal of the balloon can be used to remove saliva which collects proximal to the balloon during blood checking, and suction holes distal to the varix-compressing balloon can be used to intake and remove air, blood, and other body fluids. The Okada patent discloses that a stomach balloon can also be provided on the device therein. While providing some advantages, having suction holes as described in Okada does not provide for normal feeding and swallowing functions. Additionally, the Okada device is closed on the distal end and thus its use in connection with an endoscope is limited.
Other devices in the field known to applicant, including, for instance, the Linton and Sengstaken-Blakemore devices, all suffer from one or more of the above and other disadvantages.
In addition to the above discussion relating to treatment of esophageal bleeding sites, it is also sometimes necessary to treat bleeding sites at other points within the digestive tract, for instance within the distal stomach, pylorus and duodenum. One prior treatment of such bleeding sites has involved the use of a balloon mounted over an endoscope which is advanced down the esophagus and through the stomach, whereafter the balloon is positioned and inflated to provide pressure to the bleeding site. This treatment, however, can be used only for a brief period because it obstructs the passage of materials from the stomach into the intestine, and accordingly interrupts the normal feeding by the patient. Additionally, this treatment presents the disadvantage of not allowing the balloon to remain in place after the removal of the endoscope.
Therefore, there exists a continued need for devices for treating digestive tract bleeding sites (e.g. esophageal, upper gastric, distal gastric, pyloric and duodenal bleeding sites) which may be even more effectively used in conjunction with an endoscope, and which permit a comfortable, accurate and convenient placement, and normal swallowing and feeding functions while in place providing therapy to accelerate healing and sealing any perforation or laceration until healing can occur. The treated bleeding sites can be erosions or ulcerations of the mucosa or full thickness injuries such as lacerations or perforations. Applicant's invention addresses these needs.